Gemcitabine and Erlotinib with or without Oxaliplatin in Previously Untreated Advanced Pancreatic Cancer: A Randomized Phase II Trial
10.3349/ymj.2021.62.8.671
- Author:
Sung Hee LIM
1
;
Jina YUN
;
Min-Young LEE
;
Han Jo KIM
;
Kyoung Ha KIM
;
Se Hyung KIM
;
Sang-Chul LEE
;
Sang Byung BAE
;
Chan Kyu KIM
;
Namsu LEE
;
Kyu Taek LEE
;
Seong Kyu PARK
;
Yun Nah LEE
;
Jong Ho MOON
Author Information
1. Division of Hematology-Oncology, Department of Medicine, Soonchunhyang University Bucheon Hospital, Bucheon, Korea
- Publication Type:Original Article
- From:Yonsei Medical Journal
2021;62(8):671-678
- CountryRepublic of Korea
- Language:English
-
Abstract:
Purpose:Erlotinib has been the only targeted agent to show significantly improved outcomes in pancreatic adenocarcinoma when combined with gemcitabine. We aimed to evaluate whether the addition of oxaliplatin to a combination gemcitabine/erlotinib treatment conferred a clinical benefit in patients with locally advanced unresectable or metastatic pancreatic cancer.
Materials and Methods:Chemotherapy-naïve patients with locally advanced or metastatic pancreatic cancer were randomly assigned to receive GEMOX-T [gemcitabine 1000 mg/m2 and oxaliplatin 50 mg/m2 on day 1 (D1) and D8 plus erlotinib 100 mg daily for 3 weeks] or GT (gemcitabine 1000 mg/m2 on D1 and D8 plus erlotinib 100 mg daily for 3 weeks). The primary endpoint was the overall response rate (ORR).
Results:Between 2013 and 2016, 65 patients were assigned to a treatment group (33 in the GEMOX-T arm, 32 in the GT arm). The ORR was 18.2% [95% confidence interval (CI), 8.82–27.58] in the GEMOX-T arm and 6.2% (95% CI, 0.34–12.06) in the GT arm (p=0.051). The disease control rate was significantly superior in the GEMOX-T arm compared to the GT arm (72.7% vs. 43.8%, p=0.019). After a median follow-up of 19.7 months, the median progression-free survival (PFS) was 3.9 months for the GEMOX-T arm and 1.4 months for the GT arm (p=0.033). However, this did not translate to an improvement in overall survival. The most common grade 3 or higher hematologic adverse events were neutropenia (16.9%) and anemia (13.8%).
Conclusion:The addition of oxaliplatin to a first-line gemcitabine/erlotinib regimen demonstrated higher response rates and significantly improved PFS in patients with locally advanced or metastatic pancreatic cancer.
